Lancet Neurol:阿朴吗啡可有效改善帕金森病患者的睡眠障碍

2022-05-12 Nebula MedSci原创

夜间皮下注射阿朴吗啡可改善帕金森病患者的睡眠障碍

失眠是帕金森病患者的常见主诉,对患者的生活质量有极大的负面影响。改善睡眠和帕金森症状的药物对帕金森病引起的失眠患者有很大的好处。

本研究旨在测试夜间皮下输注阿朴吗啡在失眠的帕金森病患者中的效果和安全性。

这是一项随机、多中心、双盲、安慰剂为对照的交叉试验,招募了35-90岁的有中重度失眠的波动型帕金森病患者(失眠严重指数评分≥15分),随机分成两组,接受阿朴吗啡(最大剂量 5 mg/h)或安慰剂,首轮干预后经过14天的药物洗脱期,交换至另一组。一轮治疗包括10天的滴定阶段和7天的固定剂量阶段。在滴定阶段,根据每天评估的睡眠质量和治疗耐受性调整剂量。主要终点是帕金森病睡眠量表(PDSS)评分的变化。


帕金森病睡眠量表评分的变化对比

2017年1月31日至2021年1月29日,共招募了46位患者。25位(54%)先接受阿朴吗啡,21位(46%)先接受安慰剂。与安慰剂相比,阿朴吗啡干预后的平均PDSS评分变化明显更大(15.18 vs 5.23;治疗效应 9.95,p=0.041)。在阿朴吗啡干预期间,25位(54%)受试者报告了不良反应,在安慰剂期间,17位(37%)受试者报告了不良反应(p=0.16)。与安慰剂相比,阿朴吗啡与更频繁的头晕相关(15% vs 0,p=0.041)。


两组不良反应事件的发生情况

综上所述,根据PDSS评分的差异,夜间皮下注射阿朴吗啡可改善帕金森病患者的睡眠障碍,其总体安全性与以往关于帕金森病的研究一致。这种治疗可能有助于控制晚期帕金森病患者的中重度睡眠障碍。

 

原始出处:

Valérie Cochen De Cock, et al. Safety and efficacy of subcutaneous night-time only apomorphine infusion to treat insomnia in patients with Parkinson's disease (APOMORPHEE): a multicentre, randomised, controlled, double-blind crossover study. The Lancet Neurology. May, 2022. https://doi.org/10.1016/S1474-4422(22)00085-0

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    2023-02-08 howi
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    2022-08-13 yinhl1978
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    2022-05-13 ms7000000945970321

    学习了

    0

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    2022-05-08 showtest
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    2022-05-06 younei

    lancet上果然牛,感谢梅斯更新及时

    0

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